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Name:Nature Fusion Cold And Flu
Manufacturer:Procter & Gamble Manufacturing Company
Category:Over-the-counter (OTC) Marketed Drugs


Nature Fusion™ COLD & FLUMulti-Symptom Relief

NATURE FUSION  COLD AND FLU - acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet 
Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nature Fusion™
COLD & FLU
Multi-Symptom Relief

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash, fever or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over 2 caplets with water every 4 hrs
children under 12 yrs ask a doctor

Other information

  • save carton for full directions & warnings
  • store at room temperature

Inactive ingredients

honey, hydroxypropyl methylcellulose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, natural flavor, polydextrose, polyvinyl pyrrolidone, propylene glycol, starch, stearic acid, sucralose, talc, titanium dioxide, yellow iron oxide

Questions?

1-877-340-8824

Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

VICKS®

NEW

Nature Fusion™

COLD & FLU
Multi-Symptom Relief

Acetaminophen, Phenylephrine, Dextromethorphan

  • Aches, Fever & Sore Throat
  • Nasal Congestion
  • Cough

Non-Drowsy
Alcohol Free

Real Honey

20 Caplets

PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

NATURE FUSION   COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-496
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
Inactive Ingredients
Ingredient Name Strength
honey  
hypromelloses  
magnesium stearate  
maltodextrin  
medium-chain triglycerides  
cellulose, microcrystalline  
polydextrose  
propylene glycol  
stearic acid  
sucralose  
talc  
titanium dioxide  
ferric oxide yellow  
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 16mm
Flavor HONEY Imprint Code NF;triangle
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-496-20 10 BLISTER PACK ( BLISTER) in 1 CARTON contains a BLISTER PACK
1 2 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (37000-496-20)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 06/07/2011

Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 06/2011 Procter & Gamble Manufacturing Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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